BioPharma Drug Approval
XPOVIO® Secures NMPA Approval for Treatment of R/R DLBCL in China, Expanding Its Indications
- Following its initial approval for the treatment of relapsed/refractory multiple myeloma (R/R MM), XPOVIO® has now received approval as a monoth...
July 08, 2024 | News
Eleva's Factor H Receives Orphan Drug Designation from European Commission for Treating C3 Glomerulopathy
Eleva, a pioneer in unlocking difficult-to-produce biologics based on a breakthrough manufacturing platform, announced today that the European Commis...
July 04, 2024 | News
European Commission Approves OBGEMSA™ (Vibegron) for Overactive Bladder Treatment by Pierre Fabre Laboratories
The European Commission (EC) has authorized the marketing of OBGEMSA™ (vibegron) by Pierre Fabre Laboratories for the symptomatic treatment of overac...
July 01, 2024 | News
South Korea Approves Reimbursement for Antengene's XPOVIO®, Expanding Access to Relapsed/Refractory Multiple Myeloma Treatment
- XPOVIO® is the first XPO1 inhibitor approved for reimbursement by South Korea's National Health Insurance Service (NHIS) for the treat...
June 27, 2024 | News
Simcere Zaiming's Enlituo® Receives NMPA Approval for mCRC Treatment
Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that Enlituo® (generic name: cetu...
June 27, 2024 | News
EU Approves HUTCHMED's FRUZAQLA® for Previously Treated Metastatic Colorectal Cancer
— Approval for previously treated metastatic colorectal cancer based on results from positive, global, Phase III FRESCO-2 Trial — — FRUZ...
June 24, 2024 | News
Sarepta Therapeutics Secures FDA Approval for Expanded Use of ELEVIDYS in Duchenne Muscular Dystrophy Patients
Sarepta Therapeutics, the leader in precision genetic medicine for rare diseases, today announced U.S. Food and Drug Administration (FDA) approv...
June 21, 2024 | News
Dizal's Golidocitinib Approved in China as First JAK1-Only Inhibitor for Relapsed or Refractory Peripheral T-Cell Lymphoma
Golidocitinib is a first-in-class Janus kinase 1 (JAK1) only inhibitor approved for the treatment of r/r PTCL based on results from the multinational piv...
June 20, 2024 | News
Menarini Expands Partnership with Pharmacosmos to Bring Innovative Iron Deficiency Treatment to Singapore and Malaysia
Menarini Asia-Pacific (Menarini) announced that it has expanded its partnership with Pharmacosmos A/S (Pharmacosmos), to include exclusive rights to ...
June 19, 2024 | News
FDA Clears Zymeworks' ZW171 for Mesothelin-Expressing Cancers
“We are excited to reach this R&D milestone with ZW171, reflecting our commitment to advancing innovative therapies for cancer treatment,...
June 18, 2024 | News
SciRhom GmbH Secures Approval for Clinical Trial Application of SR-878 in Austria
SciRhom GmbH, a biopharmaceutical company pioneering the development of first-in-class therapeutic antibodies, announced the approval of a clinical trial a...
June 14, 2024 | News
Gilead and Kite Oncology Announce Approval of Yescarta® for Early Treatment of DLBCL in Singapore
**-- In ZUMA-7, Yescarta Patients with DLBCL were 2.5 Times More Likely than SOC to be Alive at Two Years Without Cancer Progression or Nee...
June 10, 2024 | News
Genetic Signatures Receives FDA Clearance for EasyScreen™ Gastrointestinal Parasite Detection Kit
Genetic Signatures Limited a global molecular diagnostics company announces that the US Food & Drug Administration ("FDA") has cleared the Compan...
June 05, 2024 | News
Telix Pharmaceuticals Completes BLA Submission to FDA for Breakthrough Kidney Cancer Imaging Agent TLX250-CDx
Telix Pharmaceuticals announces that it has completed the submission of a Biologics License Application (BLA) to the United States (U.S.) Food an...
June 03, 2024 | News
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